Subject: CDC AIDS Daily Summary for 12/23/02 Date: Mon Dec 23 10:51:05 PST 2002 (434 lines) From: National AIDS Info Clearinghouse Copyright 2002, Information, Inc., Bethesda, MD CDC HIV/STD/TB Prevention News Update Monday, December 23, 2002 The CDC National Center for HIV, STD and TB Prevention provides the following information as a public service only. Providing synopses of key scientific articles and lay media reports on HIV/AIDS, other sexually transmitted diseases and tuberculosis does not constitute CDC endorsement. This daily update also includes information from CDC and other government agencies, such as background on Morbidity and Mortality Weekly Report (MMWR) articles, fact sheets, press releases and announcements. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC HIV/STD/TB Prevention News Update should be cited as the source of the information. Contact the sources of the articles abstracted below for full texts of the articles. HEADLINES NATIONAL NEWS "U.S. Eases Drug-Patent Rules" "FDA Faults Red Cross' Handling of Blood Supply" INTERNATIONAL NEWS "A Haitian Doctor's Success in the Fight Against Disease" "A Way to Foster Employee Health" MEDICAL NEWS "Willingness to Participate and Enroll in a Phase 3 Preventive HIV-1 Vaccine Trial" "Sexually Transmitted Diseases: Report Shows Condoms Provide Inadequate Risk Reduction for STDs" LOCAL AND COMMUNITY NEWS "Singing Group United in Voices, Spirit" NEWS BRIEFS "Sweden Donates Child-Protection Fund to South Nigeria" "Tanzania Urges Clear Vision on Fighting AIDS" "Unsafe Sex on the Rise" "Sex Education Program Becomes Tongue-Tied" ************************************************************ NATIONAL NEWS ************************************************************ "U.S. Eases Drug-Patent Rules" Wall Street Journal (12.23.02)::Michael M. Phillips The Bush administration scrambled to undo the public relations damage caused when it blocked an international agreement to allow developing countries easier access to generic versions of prescription drugs to combat AIDS, malaria, cholera and other infectious diseases. Just hours after World Trade Organization talks in Geneva broke down late Friday, US Trade Representative Robert Zoellick announced that the United States would temporarily allow nations to override American drug company patents and export inexpensive, generic versions of brand-name pharmaceuticals to help African and other very poor nations. US trade officials had been working on the backup plan during the last week of negotiations, as it became apparent that Washington might soon find itself in the position of being the sole obstacle to an agreement seen by many as a humanitarian imperative. WTO members agreed in November 2001 that poor countries should, under international rules, be able to produce their own generics to deal with public health emergencies, without permission from the companies that hold the patents. Many poor nations, however, argued they did not have the industrial capacity to produce quality drugs, and asked that they be allowed to import generics. WTO members pledged to resolve that issue by the end of this year. The talks collapsed, however, over the issue of which diseases would be eligible for patent exemptions. Major developing nations, such as Brazil and India, said drugs for a vast array of diseases, including cancer, heart disease and asthma, should be covered by the exemptions. The United States, pressed by the pharmaceutical industry, wanted to limit the list to infectious diseases such as AIDS and tuberculosis. Pharmaceutical companies warned that broader exemptions would cut profits to such a degree that they would reduce their research into new drugs. The US plan - essentially a unilateral implementation of the American negotiating position - will be in place until an agreement is reached, said Zoellick. WTO members agreed to reconvene next year and try to reach a deal by Feb. 11. "FDA Faults Red Cross' Handling of Blood Supply" Los Angeles Times (12.21.02)::Charles Ornstein; Megan Garvey US Food and Drug Administration regulators on Friday disclosed widespread problems with the screening, storage and distribution of blood by the American Red Cross, calling into question the safety of the nation's blood supply. The FDA cited more than 200 safety violations and deficiencies in its preliminary inspection report, the latest since the Red Cross was first ordered by a federal court nearly a decade ago to correct systemic problems - including testing and tracking of donations. Officials said they were still trying to determine whether the latest violations, affecting a small portion of the Red Cross' inventory, resulted in patients becoming sick from transfusions of contaminated blood. "I am troubled by the apparent lapses in blood safety practices," said Dr. Mark McClellan, FDA commissioner, in a statement released Friday. "Our observations appear to show continuing evidence of a culture that is willing to accept noncompliance, as in many previous inspections." The FDA's findings, contained in a 45-page report, were the result of an eight-month inspection at Red Cross biomedical headquarters in the Washington, D.C. area. Regulators said the organization was unable to account for small amounts of blood infected with HIV and human cytomegalovirus, a common infection potentially fatal for newborns of newly infected women and those with compromised immune systems. Inspectors also found evidence of employees falsifying records and shipping orders without completing testing, as well as instances of blood products that were labeled unsuitable for release and then released anyway. The report noted that employees who saw problems feared coming forward because of possible retaliation. FDA officials say there is no risk associated with donating blood. They also encouraged people needing blood transfusions to get them. "The risk of not receiving a blood transfusion far outweighs the risk of receiving blood," said FDA spokesperson Jason Brodsky. ************************************************************ INTERNATIONAL NEWS ************************************************************ "A Haitian Doctor's Success in the Fight Against Disease" New York Times (12.22.02)::David Gonzalez Hope is an elusive commodity in Haiti. But Dr. Jean W. Pape has managed to slow the HIV/AIDS epidemic, by nimbly adapting his medical techniques to the country's political upheaval, withering poverty and crumbling infrastructure. Pape has been so successful that Haiti is the first country in the Western Hemisphere to receive a grant from the Global Fund to Fight AIDS, Tuberculosis and Malaria. In awarding Haiti $25 million, international officials called the treatments and methods devised at the Gheskio Centers, which Pape directs, and other clinics a model for how poor countries with few resources can combat AIDS, and the tuberculosis and diarrhea that often attack people with the disease. Gheskio has had impressive results fighting severe diarrhea with antibiotics, has developed methods of diagnosing STDs and has found some less expensive drug combinations to treat AIDS. It and other private groups use funds provided by foundations and foreign governments to buy the medicines, which are priced far beyond the reach of most Haitians. The Global Fund grant will provide medication for about 1,200 more people. The UN Development Program and the Sogebank Foundation, the philanthropic branch of Haiti's leading bank, will manage the funds, which are expected to arrive this month and to be used over a two-year period. Anil Soni, adviser to the fund's executive director, said the arrangement aimed to maximize efficiency and nurture cooperation between the public and private sectors. If it works, the fund could eventually provide Haiti as much as $67 million over five years, Soni said. Pape's group now plans to train staff from government clinics as part of his project's activities financed by the Fund. He is confident that with enough resources, the country can hold the line on the disease until a vaccine is discovered. "A Way to Foster Employee Health" Los Angeles Times (12.20.02)::Solomon Moore A UN report released last month names sub-Saharan Africa as the focal point of the pandemic. Stephen Lewis, UN special envoy for HIV/AIDS for Africa, said the disease has devastated the area's agricultural sector and driven a severe food shortage. Businesses suffer from increased absenteeism and rising recruitment and training costs as employees with HIV/AIDS sicken and die. Debswana Diamond Co. in Botswana is the first company in the region to offer voluntary HIV testing and to cover costs of employee's antiretroviral drugs. "Debswana is the model for our country," said Dr. Banu Khan, head of Botswana's AIDS programs. "Antiretroviral therapies will lead to AIDS prevention, they will prevent children from becoming orphans, they will prolong life." Other companies have followed Debswana's lead. In South Africa, DaimlerChrysler, Coca-Cola and Barclay's Bank are among the dozens of businesses offering antiretroviral treatment and AIDS awareness programs. "We're stepping in because the government isn't," said Errol Sackstein, general director of pen manufacturer Bic South Africa. Brian Brink, senior vice president of mining conglomerate Anglo American, said he recognized the "monstrous challenge facing [South Africa's] government in dealing with people who are unemployed, have poor nutrition, no sanitation, lack housing. But you can start, and I would argue that you could begin with the economically active people that you need to keep the country moving." Brink noted that providing AIDS therapies was a matter of enlightened self-interest for his company. "When ... you've got sickness and death all around you, when you're going to funerals every weekend - all these things are going to have a negative impact on morale and productivity," he said. As welcome as these private programs are, most companies only provide medicine for employees and a spouse. Many African men have more than one wife, and no medicine is provided for the children. Both patients and businesses suffer the stigma HIV/AIDS carries in African culture. ************************************************************ MEDICAL NEWS ************************************************************ "Willingness to Participate and Enroll in a Phase 3 Preventive HIV-1 Vaccine Trial" Journal of Acquired Immune Deficiency Syndromes (12.15.02) Vol. 31, No. 5, P. 521-528; Jacqueline M. O'Connell; Robert S. Hogg; Keith Chan; Steffanie A. Strathdee; Nancy McLean; Steve L. Martindale; Brian Willoughby; Robert Remis Characterizing high-risk populations who are willing to participate (WTP) in HIV vaccine trials is important for assessing the feasibility of large-scale efficacy trials. This study examined WTP in an HIV vaccine trial among participants in an ongoing prospective study of HIV incidence and risk behaviors among young gay and bisexual men in Vancouver, British Columbia, Canada. The authors identified independent predictors of being WTP in an HIV vaccine trial and considered the implications of these findings for the design and implementation of phase 3 trials. In addition, they examined self-reported reasons for not participating in an ongoing phase 3 vaccine trial. In a subanalysis, the authors assessed changing WTP in HIV vaccine trials from 1997 to 2001. Since May 1995, young gay and bisexual men have been recruited into the study through outreach at gay community events, community health clinics or local physicians' offices, where they complete a confidential self-administered questionnaire and provide a blood sample for HIV testing. Men are eligible to participate if they are between 15 and 30 years of age, live in the greater Vancouver region, and have not previously tested HIV-positive. Follow-up visits are conducted annually. Participants were provided with pre- and post-test HIV counseling by trained personnel at every visit. Information was collected on sociodemographic characteristics, sexual behaviors with men, and psychosocial variables. Self-reported participation in the ongoing phase 3 AIDSVAX B/B trial and reason for not participating in this vaccine trial were collected from seven specific questions included in the Vanguard Project questionnaire since 1999. The AIDSVAX B/B trial is an international, double-blind, placebo-controlled study of the rgp120/HIV-1 vaccine. In this trial, subjects are randomized in a 2:1 ratio to receive either vaccine or placebo at months 0, 1, 6, 12, 18, 24, and 30. Participants were excluded if they had not engaged in anal intercourse with a male partner at least once in the previous year or if they were in monogamous relationships with the same seronegative male partner over the same time period. The Vanguard Project did not actively recruit participants into the AIDSVAX B/B trial; however, the participants were informed of the trial and educated about basic trial concepts using mailings, e-mails, and newsletters collected at the same time as questionnaires. A total of 474 Vanguard Project participants completed a questionnaire between October 1999 and May 2001. Eligible participants included 214 who were WTP and 97 who were not WTP. The 129 participants who were unsure of their WTP were considered separately. Participants ineligible for this study included 13 respondents who were HIV-positive and 21 who were already participating in the AIDSVAX B/B trial in Vancouver. Gay and bisexual men who expressed WTP in an HIV vaccine trial were more likely to be socioeconomically disadvantaged and sexually risky and to have a high-perceived risk of HIV infection. Reasons for not enrolling in the AIDSVAX B/B phase 3 trial in Vancouver included fear of infection, serious health problems, and being denied health insurance or having missed the deadline for enrollment. Comparing WTP in 1997 in the context of a hypothetical trial with WTP in 2001 in the context of the ongoing AIDSVAX B/B phase 3 trial, there is evidence of a decline in interest in vaccine trial participation since 1997. The authors suspect that self-reported willingness to enroll in 1997 did not translate into actual enrollment into the AIDSVAX B/B trial as measured in 2001, because of lack of complete or appropriate information on vaccine trial concepts. Thus, a comprehensive approach to educating communities and trial participants may help to improve community and participants' knowledge about preventive HIV vaccine trials - especially ongoing trials - and inform perceptions of trial-related risks and benefits. "Sexually Transmitted Diseases: Report Shows Condoms Provide Inadequate Risk Reduction for STDs" Virus Weekly (12.17.02) A new scientific report, "Sex, Condoms, and STDs: What We Now Know," released by the Medical Institute for Sexual Health, reveals that condoms, even when used 100 percent of the time, fail to reduce the risks of some of the most common STDs to an acceptable level. The report reviewed findings of all significant research and professional presentations about the ability of condoms to reduce the risk of STDs. The report is authored by some of the nation's leading experts on STDs and condom research. "America is facing an epidemic of STDs - more than 15 million new STD infections per year," commented Joe S. McIlhaney Jr., MD, president of the Institute. "It is imperative that Americans understand what the science says about the limits of condoms in keeping them safe from STDs, many of which can have life-altering consequences, including infertility and cancer." Key findings include: *Condoms must be used 100 percent of the time and used correctly to avoid STD infection and potential disease from infected partners. *Even 100 percent condom use does not eliminate the risk of any STD including HIV. *100 percent use of condoms for many years is so uncommon that it is almost a purely theoretical concept except for very few, very meticulous individuals. *There is no evidence of any risk reduction for sexual transmission of HPV even with 100 percent condom use. *Syphilis transmission is reduced from 29-50 percent with 100 percent condom use, leaving 50-71 percent relative risk of infection. *Chlamydia and gonorrhea transmission is reduced by approximately 50 percent with 100 percent condom use leaving an approximate 50 percent relative risk of infection. *HIV sexual transmission is reduced by approximately 85 percent with 100 percent condom use leaving an approximate 15 percent relative risk of infection. *For the approximately 20 other STDs, not enough data exist to say whether condoms offer any risk reduction from sexual transmission. ************************************************************ LOCAL AND COMMUNITY NEWS ************************************************************ "Singing Group United in Voices, Spirit" Dallas Morning News (12.20.02)::Frank Trejo At the Turtle Creek Chorale's annual holiday concert in Dallas, Texas, 138 poinsettias decorated the stage. The plants honor each member the group has lost to HIV/AIDS since 1986, when the tradition began. Founded in 1980, Turtle Creek Chorale has become one of the foremost male choral groups in the country. It has more than two dozen recordings and has toured throughout the United States and in Europe. In 1994, the chorale was featured in an Emmy-Award- winning documentary produced by KERA-TV, "After Goodbye: An AIDS Story." Dr. Timothy Seelig, the chorale's artistic director, has also become a grief counselor and advocate. The group provides physical and financial assistance to HIV/AIDS patients, as well as emotional support. "HIV can be a very lonely disease. Persons suffering from HIV can experience discrimination, abandonment and loneliness," said Seelig. "They are part of my family," said Keith Lasley, a 40-year- old Dallas chorale member who has had HIV since the mid-1980s. The group helps some members set goals, they say. Don Dureau, 60, who has been HIV-positive for 11 years, says that in the early 1990s, the group discussed canceling tours because some members might be too ill to travel. "I remember getting up and telling people that having things to look forward to in the future gives you a reason for wanting to live," he said. Seelig said some feared for the chorale's future during the height of the AIDS epidemic. Now that medical advances have slowed the number of deaths, issues around the disease have shifted. One 18-year-old member, he noted, is "unaware totally of the destruction AIDS has caused." Such lack of knowledge may affect the growing number of young gay men not practicing safe sex. CDC studies in Atlanta have found increasing HIV infection rates for young gay and bisexual men. ************************************************************ NEWS BRIEFS ************************************************************ "Sweden Donates Child-Protection Fund to South Nigeria" Xinhua News Agency (12.12.02) The Swedish International Development Cooperation Agency has decided to donate $900,000 to UNICEF's model youth resource learning center in southern Nigeria. Birgitta Alani, Swedish Ambassador to Nigeria, has said the project is part of Sweden's decision to support ongoing efforts in West Africa, and especially in Nigeria, Burkina Faso and Mali, to promote children's rights and to combat child trafficking. "The aim of the program is to reduce the underlying causes of child trafficking, youth violence and HIV/AIDS prevalence among adolescents in Edo and Delta states," Alani said in a statement. "Tanzania Urges Clear Vision on Fighting AIDS" Xinhua News Agency (12.16.02) While officially opening the 2nd National Mutisectoral AIDS conference in Dar es Salaam, Tanzania, Vice President Ali Mohammed Shein criticized some regions for not making progress on reducing the number of HIV/AIDS patients under the circumstances of fast development of medical knowledge, technology and skills. He said that the country needs to break out of the constraints which prevent the government and the community from winning the battle against HIV/AIDS. Shein said the conference should address itself to those challenges and come out with practical recommendations that could take the country to new horizons of intensified and expanded multisectoral responses to HIV/AIDS. "Unsafe Sex on the Rise" Australian (12.11.02)::Misha Schubert Sexually transmitted infections in Australia have doubled in five years as young people ignore calls for them to abstain or practice safer sex, according to Sexual Health and Family Planning Australia. "A lot of young people who become sexually active are often under the wrong impression that if they have the same partner for two or three experiences, they think they are a couple," said the body's executive director Roberto Rojas- Morales. The rate of chlamydia doubled between 1996 and 2000, to affect 88 in 100,000 people. "Sex Education Program Becomes Tongue-Tied" Reuters Health (12.20.02) Teachers in Texas' Leander Independent School District want to be able to answer students' questions about the risks of oral and anal sex but they dare not speak the words in the classroom because of parental objections. Educators became concerned after students submitted anonymous questions to their health teachers asking if oral and anal intercourse is considered sex, and if there are health risks from AIDS and STDs. The sex education curriculum does not allow teachers to answer such questions. "We certainly need to address these things in our curriculum because they are health issues," said school district spokesperson Bill Britcher. LISD is considering adding discussion of oral and anal sex to the curriculum starting in the eighth grade, but the proposal faces opposition since some members of the curriculum advisory panel objected to the use of the words "oral" and "anal." The panel and school administrators have asked teachers to come up with a way to answer the questions without using the words in question. Britcher noted that neighboring districts in the Austin area allow teachers to use the words oral and anal, but they cannot specifically describe either act. ************************************************************ ANNOUNCEMENT: Prevention News Update will not be published Dec. 24-25. Publication will resume on Dec. 26.